Category: US Department of Health

Source: US Department of Health and Human Services – 3

For Immediate Release:
July 17, 2026

The U.S. Food and Drug Administration approved Lipfendra (enlicitide), the first oral inhibitor of proprotein convertase subtilisin/kexin type 9 (PCSK9), as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C), or “bad” cholesterol, in adults with hypercholesterolemia, including those with heterozygous familial hypercholesterolemia (HeFH).
PCSK9 inhibitors have previously been available only as injectable therapies. Lipfendra is administered as a once-daily oral tablet and provides an additional treatment option for adults who require further LDL-C reduction despite existing therapies. The approval also reflects continued advances in the development of therapies for chronic cardiovascular disease management.
“Cardiovascular disease remains the leading cause of death in the United States, and elevated LDL cholesterol is one of its most important modifiable risk factors,” said Michael Davis, M.D., Ph.D., Acting Director of the FDA’s Center for Drug Evaluation and Research. “This approval provides an additional treatment option for adults with hypercholesterolemia and reflects the FDA’s broader commitment to supporting meaningful advances in patient access and tackling chronic diseases.”
Hypercholesterolemia occurs when there is too much LDL-C in the blood. Over time, excess LDL-C can accumulate within the walls of arteries, contributing to the formation of plaques that narrow blood vessels and restrict blood flow. If a plaque ruptures, it can trigger the formation of a blood clot, increasing the risk of heart attack or stroke. Because high cholesterol typically causes no symptoms, many people are unaware they have the condition until it is detected through routine blood testing. Diet, physical inactivity, excess body weight, and inherited genetic conditions can all contribute to elevated cholesterol levels.
Several classes of medications are available to lower LDL-C, including statins, ezetimibe, and injectable PCSK9 inhibitors. Lipfendra is the first oral therapy to inhibit PCSK9.
The efficacy and safety of Lipfendra were evaluated in two randomized, double-blind, placebo-controlled clinical trials involving 3,207 adults with hypercholesterolemia, including patients with and without HeFH, who were receiving maximally tolerated statin therapy. The primary endpoint in both studies was the percent change in LDL-C from baseline to Week 24 compared with placebo.
In the first trial, which enrolled adults with established atherosclerotic cardiovascular disease (ASCVD) or those at high risk for ASCVD, participants had a mean baseline LDL-C of 96 mg/dL. Treatment with Lipfendra resulted in an average 56% reduction in LDL-C at Week 24 compared with placebo.
In the second trial, which enrolled adults with HeFH, participants had a mean baseline LDL-C of 119 mg/dL. Treatment with Lipfendra resulted in an average 59% reduction in LDL-C at Week 24 compared with placebo.
In the first trial, the frequency of adverse reactions was similar between patients treated with Lipfendra and those receiving placebo. In the second trial, the most common adverse reactions occurring more frequently with Lipfendra than placebo were diarrhea and dizziness. Across both trials, discontinuation rates due to adverse reactions were comparable between the Lipfendra-treated and placebo-recipient groups.
Lipfendra received Priority Review for this indication. The application was also reviewed under the Commissioner’s National Priority Voucher (CNPV) pilot program, which is intended to help accelerate the review of therapies that address national public health priorities.
The approval was granted to Merck Sharp & Dohme LLC.

Consumer:888-INFO-FDA

###

Boilerplate

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products.

Content current as of:
07/17/2026

Regulated Product(s)

Follow FDA

Source: US Department of Health and Human Services – 3

This recall involves correcting certain devices, and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without correction.
Affected Product

The FDA is aware that Arrow International has issued a letter to affected customers recommending certain convenience kits be corrected prior to continued use. Affected devices:

Arrow Kits and Sets that contain 0.9% sodium chloride (10mL saline solution ampule) and Lidocaine 
Arrow Kits and Sets containing Lidocaine and Bupivacaine
Full list of affected products

What to Do
Do not use the affected saline ampule and lidocaine included in affected Arrow kits.
On April 2026, Arrow International sent all affected customers a letter recommending the following actions:

Do not use the affected 0.9% sodium chloride (10mL saline ampule) and lidocaine included in affected Arrow kits. Do not use the Lidocaine and Bupivacaine in the kits.
At the point of use, discard the affected saline, lidocaine and bupivacaine ampules upon opening the kit.
Obtain 0.9% sodium chloride (saline solution), bupivacaine and lidocaine separately through your facility pharmacy and prepare / administer it per institutional protocols prior to the procedure.
Ensure all relevant personnel in your organization are informed of this notice.

Reason for Correction
Arrow International, a Teleflex subsidiary, is removing saline, bupivacaine and lidocaine ampules manufactured by Huons Co. Ltd from certain convenience kits. Huons Co., Ltd. initiated a recall of saline, bupivacaine and lidocaine.
Risks of using compromised injectables include infection, inflammatory response and/or reduced or lack of anesthetic effectiveness.  Use of Lidocaine or bupivacaine with reduced or lack of anesthetic effectiveness, may result in ineffective pain control leading to varying degrees of pain, surgical complications, such as emergency conversion   and/or repeat or delayed treatment, and/or patient distress.
As of April 20, 2026, Arrow International has reported no serious injuries and no deaths associated with this issue.
Device Use
Convenience kits contain various surgical instruments, dressings and/or other materials, and pharmaceutical components that are intended to be used during various surgical procedures.
Contact Information
Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Arrow International at Recalls@teleflex.com or 1-866-396-2111.
Additional FDA Resources

Additional Company Resources
Company-provided information is posted here by the FDA as a public service.

Unique Device Identifier (UDI)
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from distribution to use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified more quickly, and as a result, problems potentially resolved more quickly.

How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

Content current as of:
07/16/2026

Regulated Product(s)

Source: US Department of Health and Human Services – 3

This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.
Affected Product
The FDA is aware that B. Braun Medical, Inc. has issued a letter to affected customers recommending certain spinal anesthesia kits be removed from where they are used or sold.
Affected devices:

B. Braun PENCAN Spinal Needle Procedure Kits
B. Braun Spinocan Spinal Needle Procedure Kits
B. Braun Spinocan Spinal Tray Spinal Needle Anesthesia Procedure Kits

Full List of Affected Product
What to Do
Do not use affected product. Identify affected product, cease use and distribution, and return to B. Braun Medical, Inc.
On April 26, B. Braun Medical, Inc., sent all affected customers a letter recommending the following actions:

Immediately examine inventory for affected product
Discontinue use, stop distribution, and quarantine product subject to recall immediately
Return affected product to B. Braun
If you have further distributed the product, please forward this notice to your consignees. This recall is to be extended to the hospital/healthcare facility level.  

Reason for Recall
B. Braun Medical, Inc. is removing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP from certain convenience kits. Huons Co., Ltd. initiated a recall of Bupivacaine HCL in Dextrose Injection, USP. Risks of using compromised injectables include infection, inflammatory response and/or reduced anesthetic effectiveness. When used in the neuraxial space, there is a risk of cerebral fluid contamination and meningitis that may progress to encephalitis and emergency conversion to general anesthesia.
As of April 24, B. Braun has reported 35 serious injuries and no deaths associated with this issue.
Device Use
Convenience Kits are two or more separate types of finished products packaged together for the convenience of the user. Kits (or trays) are often utilized in the surgical arena. Generally, the kits involved in this recall are used for pain management and regional anesthesia.
Contact Information
Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact B. Braun Medical, Inc. at recalls@bbraunusa.com or via phone at (844) 903-6417.
Additional FDA Resources

Unique Device Identifier (UDI)
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.  

How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program. 

Content current as of:
07/16/2026

Regulated Product(s)

Source: US Department of Health and Human Services – 3

Summary

Company Announcement Date:
July 15, 2026
FDA Publish Date:
July 15, 2026
Product Type:
Food & BeveragesAllergens
Reason for Announcement:

Recall Reason Description
May Contain Undeclared Peanuts

Company Name:
Khong Guan Corporation
Brand Name:

Brand Name(s)
Khong Guan Corporation

Product Description:

Product Description
Glutinous Rice Balls with Black Sesame Filling and Black & White Glutinous Rice Balls with Black Sesame Filling

Company Announcement
Khong Guan Corporation (Union City, CA) is recalling specific lots of “Glutinous Rice Balls with Black Sesame Filling” and “Black & White Glutinous Rice Balls with Black Sesame Filling” in their recall expansion because they may contain undeclared peanuts. People who have an allergy or severe sensitivity to peanuts run the risk of serious or life-threatening allergic reactions if they consume these products.
Product Details:

(1) Glutinous Rice Balls with Black Sesame Filling; UPC 6908791000053; Date Codes (“Use By” on the back panel): 9/22/2027 and 10/19/2027
(2) Black & White Glutinous Rice balls With Black Sesame Filling; UPC 6908791000084; Date Code (“Use By” on the back panel): 10/19/2027
Size/Packaging: 14.1 oz flexible plastic bag (same for both)
Distribution: AZ, CA, CO, HI, NJ, NV, OR, TX, WA – online and retail stores. (June 2, 2026 to July 8, 2026)

No illnesses have been reported to date. The recall was initiated after a customer reported suspected peanut content in the Glutinous Rice Balls with Black Sesame Filling. Following further review, the scope has been expanded to include additional item of Black & White Glutinous Rice Balls with Black Sesame Filling (UPC 6908791000084), due to similar instances of undeclared peanut allergens. These products were distributed in packaging that did not disclose the presence of peanuts.
Consumers who purchased the affected product are urged not to consume it and should return it to the place of purchase for a full refund.
Consumers with questions may contact Khong Guan Corp. at 1-877-889-8968. From 9:00 AM to 4:30 PM PST.
Link to Initial Press Release

Company Contact Information

Consumers:
Khong Guan Corp.
1-877-889-8968

Product Photos

Content current as of:
07/15/2026

Regulated Product(s)

Topic(s)

Follow FDA

Source: US Department of Health and Human Services – 3

For Immediate Release:
July 15, 2026

To advance the Trump administration’s actions to safeguard American agriculture, the U.S. Food and Drug Administration today issued an Emergency Use Authorization (EUA) for Ivermectin Liquid for Horses (ivermectin oral solution) for the short-term prevention of New World screwworm (NWS) infestations (myiasis) in horses. The product is authorized for use when administered within 24 hours of birth or at the time of initial wound care. Ivermectin Liquid for Horses is not for use in species other than horses.
“The Trump administration will use every available tool to stop New World screwworm from threatening America’s horses and livestock,” said U.S. Health and Human Services Secretary Robert F. Kennedy, Jr. “This EUA expands our defenses, strengthens our preparedness, and helps protect the animals, producers, and communities that drive American agriculture.”
“President Trump has directed his entire administration to do what it can to combat and stop the spread of New World screwworm. We at USDA have been working with our federal partners to prepare for any potential infestation of animals that may occur as a result of New World screwworm, and today’s announcement is another step in the right direction,” said U.S. Department of Agriculture Secretary Brooke L. Rollins. “HHS and FDA have stepped up to the plate and have moved at Trump speed to authorize as many treatments as needed to protect our livestock, wildlife, and companion animals. I am thankful to Secretary Kennedy for getting this authorization across the finish line and ensuring our horse population has access to preventative measures, should they need it.”
NWS is a parasitic fly whose larvae feed on the living tissue of warm-blooded animals. Newborn animals with healing umbilical wounds and animals with open wounds are particularly vulnerable to infestations, as NWS flies are attracted to these sites to lay their eggs. Left untreated, infestations can be severe and life-threatening.
Based on the totality of the scientific evidence available, the FDA has concluded it is reasonable to believe that Ivermectin Liquid for Horses may be effective in the short-term prevention of NWS myiasis in horses when used as authorized, and the known and potential benefits of the product outweigh its known and potential risks.
“The Trump administration is leaving no stone unturned in our fight to shield American ranchers, livestock producers, and the agricultural economy from this threat,” said Acting FDA Commissioner Kyle A. Diamantas, J.D. “This marks the FDA’s 11th Emergency Use Authorization deployed against New World screwworm, and we will continue to use all available authorities, act with maximum speed, and deliver tools to protect animals in the U.S.”
This EUA authorizes Ivermectin Liquid for Horses only for short-term prevention of NWS myiasis, not treatment. If a wound is already infested, or if an infestation develops after administering Ivermectin Liquid for Horses, contact a veterinarian to discuss treatment options.
“This authorization provides a short-term prevention option for horses, but owners and veterinarians should be aware of the limitations,” said Timothy Schell, Ph.D., director of the FDA’s Center for Veterinary Medicine. “This product’s window of prevention lasts no more than 24 hours, so it is important that the product be used alongside other preventive measures such as bandaging, repellents, and other fly-control methods.”
Ivermectin Liquid for Horses is a clear, ready-to-use solution and can be administered as an oral drench or via a tube going from a horse’s nose to its stomach. This product is available only by prescription from a licensed veterinarian. Do not use this product in species other than horses.
Detailed product information about Ivermectin Liquid for Horses can be found in the Fact Sheet: Emergency Use Authorization of Ivermectin Liquid for Horses (ivermectin oral solution) for New World Screwworm (NWS).  
This EUA will be effective until it is revoked or the HHS Secretary terminates the declaration that the potential public health emergency presented by NWS justifies the emergency use authorization of animal drugs for NWS.
Ivermectin Liquid for Horses is sponsored by Alberta Vet Labs Ltd. based in Canada.
Related Information

Related Information

Consumer:888-INFO-FDA

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Boilerplate

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products.

Content current as of:
07/15/2026

Regulated Product(s)

Follow FDA

Source: US Department of Health and Human Services – 3

CDRH is issuing this Early Alert to notify the public of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available.
Affected Product

Figure 1. Astral 150.
The FDA is aware that Resmed has issued a letter to affected customers recommending that certain Astral 100 and Astral 150 ventilators be corrected as soon as replacement parts become available. Patients should NOT stop using the ventilator unless they are instructed by their clinician.
Affected Devices:

Astral 100 ventilators built prior to October 2024

Astral 150 ventilators built prior to October 2024

Serial Number: less than 22241890149
Unique Device Identifier (UDI): 00619498270033

Astral 100 PCBA spare parts built prior to October 2024

Characters 2–8 on the PCBA or ventilator user interface are less than 2707658
Unique Device Identifier (UDI): 00619498290512

Astral 150 PCBA spare parts built prior to October 2024

Box Serial Number: less than 22241978070
Unique Device Identifier (UDI): 00619498290529

What to Do
These devices are used to provide continuous or intermittent ventilatory support to patients at home, in the hospital, and portable situations, and interrupted or failed therapy may result in serious injury or death. DO NOT stop using these ventilators. Immediately determine whether the main board currently installed in the ventilator is affected by this issue. Ventilators fitted with a main board that is not affected by this issue are not impacted. Ensure all affected users have backup ventilation equipment available and ready for immediate use while awaiting the correction from Resmed.
On June 25, Resmed sent all affected customers a letter recommending the following actions:
Patients:

Do not stop using your ventilator unless advised by your clinician.
Your healthcare provider or service provider will contact you if your ventilator requires inspection, servicing, or corrective action.
All caregivers should be appropriately trained, have up-to-date training, and feel confident in responding to alarms and emergency situations. If you are unsure how to respond to an alarm, contact your healthcare provider or clinician for guidance. 
Ensure that backup ventilation equipment (such as a backup ventilator or manual resuscitator) is available, regularly checked, and ready for immediate use if needed.
For ventilator-dependent patients, always have alternate ventilation equipment available, such as a back-up ventilator, manual resuscitator or similar device. Failure to do so may result in patient injury or death. 
Ventilator-dependent patients should be continuously monitored by qualified personnel or adequately trained carers. These personnel and carers must be capable of taking the necessary corrective action in the event of a ventilator alarm or malfunction.

Health Care Providers and Distributors:

Check all ventilators to determine whether the main board currently installed is affected by this issue. If a ventilator has previously had its PCBA replaced, the replacement PCBA should be verified. Ventilators fitted with a main board that is not affected by this issue are not impacted.
Immediately provide a copy of this notice, together with the physician letter and patient/carer communication, to all relevant healthcare professionals, patients, and carers. 
Reinforce adherence to the Astral User Guide and Clinical Guide instructions, including ensuring that ventilator-dependent patients are appropriately monitored, that care providers are trained and confident in responding to ventilator alarms and emergency situations, and that appropriate alternative ventilation equipment is functional, regularly checked, and immediately available where required. 
Do not remove an affected ventilator from use unless an appropriate alternative means of ventilation is immediately available. If an affected ventilator becomes inoperable, it should be removed from use and replaced with an appropriate alternative means of ventilation. Patients should continue therapy unless otherwise directed by their treating clinician. 
Review and assess the affected patients’ clinical needs and their clinical risk category (Tier 1, Tier 2 or Tier 3) using Appendix A (provided in Resmed’s health care provider letter) and clinical judgement. 
Arrange inspection of affected ventilators in accordance with the Phase 1 Inspection and Correction Strategy in Appendix A. Return ventilators to an authorized service center when required. 
Continue to follow Resmed service and maintenance processes, including the 2-year preventative maintenance schedules and current Technical Service instructions (including Tech Note 1063720 and subsequent updates). 
Identify affected ventilators within your control and review the serial number list provided by Resmed. 
Monitor communications from Resmed regarding this issue. Resmed will provide further updates and instructions directly to affected customers via email or other appropriate communication channels as additional information becomes available. 
For new patients, prioritize alternative ventilator options due to the significantly constrained availability of Astral ventilators.

Service Centers:

Identify any PCBA spares in your possession with a serial number below 22241978070, remove them from available service inventory to prevent further use, and contact
Resmed for further instructions. 
Perform servicing, corrective actions and data collection in accordance with the latest Technical Service instructions, including Tech Note 1063720. As Technical Service instructions are updated, progressively expand replacement activities in line with updated guidance.

Check this web page for updates. The FDA is currently reviewing information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available.
Reason for Alert
Resmed stated that in a subset of Astral 100 and Astral 150 ventilators, they have identified that a component, called a supercapacitor, may leak over time. The leakage may damage specific circuitry on the printed circuit board assembly (PCBA). This can result in the ventilator inadvertently entering a fail-safe state.
If the issue occurs while the ventilator is delivering therapy:

Therapy stops. 
A high-priority audible alarm (maximum volume alarm) activates. 
The user interface may display therapy alarms and a Safety System Fault red screen. 
When the “Vent Stop” button is pushed, the user interface displays System Fault 140.
If the issue occurs while the ventilator is in standby:

A maximum volume alarm activates. A user interface message may not be displayed. If therapy is initiated, therapy will not start.
In both cases the ventilator is no longer able to deliver therapy. Alternative means of ventilation must be provided.
Patients who are unable to maintain spontaneous ventilation, or who do not have access to adequate monitoring or alternative ventilation, may be at risk of serious injury or death if the fail-safe state is entered and therapy is not restored.
At this time, the availability of PCBAs is significantly constrained, and it is not possible to immediately correct all affected ventilators. As a result, Resmed is implementing a prioritized and phased approach initially focused on inspection and risk mitigation activities during routine service interactions for patients at highest clinical risk.
Resmed is continuing to evaluate potential additional corrective action pathways for the affected population. Further communication and updated instructions regarding any additional actions that may be required will be provided as they become available.
These supply constraints are also expected to affect the availability of new Astral ventilators. Accordingly, alternative ventilator options should be prioritised for new patients, noting that availability may vary by product and country.
As of June 23, Resmed has reported five serious injuries and no deaths associated with this issue.
Device Use
The Astral 100 and Astral 150 ventilators provide continuous or intermittent ventilatory support for patients weighing more than 5 kg who require mechanical ventilation. The ventilators are intended for use in home, institutional/hospital, and portable settings for both invasive and non-invasive ventilation.
Contact Information
Customers in the U.S. with adverse reactions, quality problems, or questions about this issue should contact their local Resmed representative via www.resmed.com/contact.
Unique Device Identifier (UDI)
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.

How do I report a problem?  
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

Source: US Department of Health and Human Services – 3

The affected products and recommendations for what to do with the devices below have not changed.
This recall involves correcting devices, and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without correction.
Affected Product
The FDA is aware that Baxter has issued an Urgent Medical Device Correction notice to affected customers recommending all Volara System patient circuits be corrected prior to continued use. 
Affected devices:

Product Description
Product Code
UDI-DI

VOLARA P.CIRCUIT KIT, HC
M08085
00887761985018

VOLARA P.CIRCUIT 5KIT
M08270
10887761985015

VOLARA P.CIRCUIT KIT AC
M08473
00887761981492

VOLARA P.CIRCUIT 5KIT AC
M08474
10887761981499

What to Do
Carefully inspect the nebulizer cup for damage before each use. Ensure the nebulizer cup is full and securely locked during assembly. If leakage is observed, discontinue the use of that nebulizer and replace the patient circuit.
On May 21, Baxter sent all affected customers a letter recommending the following actions:

Before each use, carefully inspect the nebulizer cup for damage and ensure it is fully and securely locked during assembly, following the instructions enclosed in Baxter’s Urgent Medical Device Correction notice. 
If leakage is observed during therapy, discontinue the use of that nebulizer and replace the patient circuit. 
Home Care Patients: If leakage persists or you are unsure whether to continue therapy, contact your healthcare provider or care team for guidance.
Nebulizer cups with patient circuits are routinely replaced as part of normal therapy usage. Additional patient circuits can be provided through standard distribution.
If you distributed this product to other facilities or departments within your institution, please forward a copy of this communication to them. 
If you are a dealer, wholesaler, distributor/reseller, or original equipment manufacturer (OEM) that distributed any affected product to other facilities, please notify your customers of this urgent medical device correction. Please continue distributing this communication to all new customers until the IFU updates are complete. Baxter will advise when the new IFU is released.

Reason for Correction
Baxter stated that Volara System single-patient use circuits may experience air and medication leakage from the nebulizer cup during therapy. The leakage can lead to patient desaturation and ineffective nebulization, impacting the delivery of prescribed therapy. The issue has been associated with improper locking of the nebulizer after medication is added to the cup.
If the nebulizer cup is damaged or is not properly engaged during assembly, this issue could lead to medication leakage and ineffective delivery of therapy. If less medication than intended reaches the lungs, the mechanical benefits may still occur; however, the pharmacologic benefit may be reduced or lost. This may lead to serious or critical adverse health consequences such as increased airway inflammation and mucus retention (which may lead to mucus plugging and/or infection), prolonged coughing, worsening shortness of breath, and/or reduced oxygenation. Leaks in the breathing circuit could lead to hypoxia and hypoventilation as the patient receives lower tidal volume than prescribed and are particularly concerning for pediatric patients receiving therapy at home.
As of May 21, Baxter has reported one serious injury and no deaths associated with this issue.
Device Use
The Volara System is intended for the mobilization of secretions, lung expansion therapy, the treatment and prevention of pulmonary atelectasis, and has the ability to provide supplemental oxygen when used with an oxygen supply. The Volara System is intended to deliver therapy to adults and children over the age of two in the acute care setting, and to adults and children over the age of five in the home care setting.
Contact Information
Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Baxter at 1-800-426-4224 and select option 2. For clinical assistance with your Volara therapy, please contact Baxter’s Clinical Support team at 1-800-397-9071.
Additional FDA Resources

FDA Enforcement Report
CDRH Medical Device Recall Database

Unique Device Identifier (UDI)  
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.

How do I report a problem?  
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.  
Timeline of Communication Updates

Date
Actions

07/14/2026
The FDA updated this communication to inform the public that this issue has been classified as a Class I Recall. 

06/11/2026
The FDA issued an Early Alert communication to notify the public of a potentially high-risk device issue. 

Content current as of:
07/14/2026

Regulated Product(s)

Source: US Department of Health and Human Services – 3

This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.
Affected Product

The FDA is aware that Medtronic has issued a letter to affected customers recommending certain lots of the Harmony Delivery Catheter System (DCS) used for insertion of the Medtronic Harmony transcatheter pulmonary valve (TPV) be removed from where they are used or sold.
Affected devices:

Device Descriptive Name
Model Name
UDI-DI

Harmony Delivery Catheter System
HARMONY-DCS
00763000341367

Harmony Delivery Catheter System
HARMONY-DCS
00763000544027

Harmony Delivery Catheter System
HARMONY-DCS
00763000520151

Harmony Delivery Catheter System
HARMONY-DCS
00763000582951

Harmony Delivery Catheter System
HARMONY-DCS
00763000918712

Full List of Affected Device Lot Numbers
What to Do
Do not use affected products. No additional actions are required for patients with a successfully implanted Harmony TPV.
On May 28, 2026, Medtronic sent all affected customers a letter recommending the following actions:

Immediately quarantine and return the affected products to Medtronic.
Share the Medtronic notification with implanters of the affected products within your organization and their teams. If any of the affected products have been forwarded from your facility to another facility, please notify the other facility about the Medtronic notification.
Because the potential tip detachment is limited to the Harmony DCS during delivery of the Harmony TPV, there are no additional actions required for patients with a successfully implanted Harmony TPV. These patients should continue to be monitored according to each practice’s standard clinical follow-up procedures.

Reason for Recall
Medtronic stated that certain lots of the Harmony DCS used for insertion of the Medtronic Harmony TPV have an increased risk of distal tip detachment. Detachment of the distal tip during the implant procedure will require a secondary intervention to remove the tip, either by endovascular retrieval or surgical intervention. Additional potential patient risks associated with this issue may include prolonged procedure time, extended fluoroscopy time, occlusion, tissue damage, pulmonary regurgitation, embolism, and hemorrhage. This issue does not involve the Harmony TPV.
As of May 14, 2026, Medtronic has not reported any serious injuries or deaths associated with this issue.
Device Use
The Harmony DCS is a single use, intravascular, over-the-wire delivery catheter incorporating a loading system. It is used in a catheterization lab to facilitate placement of the Harmony TPV within a patient’s anatomy. The Harmony TPV System is indicated for use in the management of pediatric and adult patients with severe pulmonary regurgitation who have a native or surgically repaired right ventricular outflow tract and are clinically indicated for surgical pulmonary valve replacement.
Contact Information
Customers in the U.S. with adverse reactions, quality problems, or questions about this issue should contact Medtronic at rs.structuralheartfieldassurance@medtronic.com or (800) 854-3570.
Additional FDA Resources

Unique Device Identifier (UDI)
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from distribution to use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified more quickly, and as a result, problems potentially resolved more quickly.

How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

Content current as of:
07/13/2026

Regulated Product(s)